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510(k) K761033

COMPUTERIZED TOMOGRAPHY SCANNER by Syntex Corp. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1976
Date Received
November 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Syntex Corp.

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  • K780997 — AMALGAM ALLOY (July 27, 1978)
  • K780769 — S-100 CT SCANNER (June 2, 1978)
  • K780483 — FIBER OPTIC HANDPIECE (April 28, 1978)
  • K761331 — OPUS I OPTION - FIBER OPTIC L SYSTEM (January 3, 1977)
  • K761330 — SYNTEX SYSTEM 6000 (December 30, 1976)
  • K761332 — HI-SENSITIVITY MODE OPTION FOR S60-1A (December 30, 1976)
  • K761264 — OPTIONS FOR STAR DENTAL OPUS I (December 23, 1976)

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